Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy

February 7, 2022 updated by: Bristol-Myers Squibb

Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis

An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

344

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1620814
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in Japan who are initiating treatment with DCV Trio therapy

Description

Inclusion Criteria:

  • Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration

Exclusion Criteria:

  • Patients who use the DCV Trio off label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Aspartate Aminotransferase (AST) elevation
Time Frame: Up to 36 weeks
measured by immunoassay
Up to 36 weeks
Incidence of Alanine Aminotransferase (ALT) elevation
Time Frame: Up to 36 weeks
measured by immunoassay
Up to 36 weeks
Incidence of Total Bilirubin (tBili) elevation
Time Frame: Up to 36 weeks
measured by immunoassay
Up to 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan
Time Frame: Up to 36 weeks
measured by adverse events
Up to 36 weeks
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
Time Frame: Up to 24 weeks
measured by number of patients
Up to 24 weeks
Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)
Time Frame: Up to 36 weeks
measured by number of patients
Up to 36 weeks
Percentage of patients to experience virologic breakthrough
Time Frame: Up to 36 weeks
measured by percentage of patients
Up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 8, 2019

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI443-144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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